About VitalTrace

VitalTrace Pty Ltd is a multi-award-winning, VC-funded Australian-based Med-tech start-up company aiming to improve outcomes for mothers and children during the childbirth process. We are doing this by developing novel cutting-edge biosensor technologies for fetal monitoring during childbirth. We believe that mothers and babies deserve the highest standard of care, and that childbirth monitoring should be accurate and allow clinicians to make informed and timely decisions.

We have a vibrant culture with a diverse, high-performing multidisciplinary team of clinicians, researchers, engineers, chemists, software developers, and data scientists all working towards the same goal The primary goal of this position is to lead the development and validation of real-time product algorithms for VitalTrace's continuous lactate monitoring biosensor. This role will use device, production, laboratory and study data to convert biosensor signals into accurate, reliable and clinically meaningful lactate outputs. The position requires expertise in applied modelling, signal processing, product algorithm development, process variation and analytical validation to support algorithms that can be locked, validated and deployed in a regulated medical device environment.

Position Responsibilities:

We may from time to time vary or modify your duties but only to those duties for which you have the skill and competence.

Product Algorithm Development:

- Design, build and refine real-time product algorithms for continuous biosensor signal processing and calibrated lactate output.
- Develop practical, traceable and explainable models that perform reliably across representative product, production and use conditions.
- Use available device, production, laboratory and study data to improve algorithm robustness and product readiness.
- Ensure algorithms are suitable for constrained compute environments and can transition from proof-of-concept to locked product implementation.
- Work with technical teams to identify key factors that influence sensor performance, signal quality and algorithm reliability.

Product Data and Performance Inputs:

- Use product, process, laboratory and study data to understand variation and improve algorithm performance.
- Work with Manufacturing, R&D; and Quality to define required data inputs, data quality expectations and validation datasets.
- Analyse product, production, storage and use-condition effects on performance at a level appropriate to product development and release.
- Support the development of traceable, model-ready datasets that connect device history, test data and performance outcomes.

Sensor Performance Translation:

- Model relationships between laboratory sensor behaviour and product performance in relevant use settings.
- Distinguish device and sensor variation from biological, environmental, workflow and reference-method effects.




- Define how findings inform algorithm inputs, performance requirements, root cause analysis or product/process improvement priorities.

Analytical Validation and Algorithm Lock:
- Define validation strategies across representative product, production and use conditions, avoiding approaches that overstate generalisability.
- Own performance analysis including variation, bias, uncertainty, range-specific performance and clinically relevant performance requirements.
- Support performance and uncertainty analysis that separates measurement, product, biological and residual algorithm contributions.
- Define algorithm lock criteria, prospective validation plans, change-control requirements and validation reports suitable for design control and regulatory review.

Signal Processing, Collaboration and Documentation:

- Design and implement biosensor signal processing, signal quality assessment and calibrated lactate output algorithms.
- Ensure algorithms use product-available or release-appropriate inputs and support transition from prototype models to locked, production-ready algorithms.
- Work closely with Manufacturing, R&D; Scientists & Engineers, Data Engineering, Quality, Regulatory, Clinical/Preclinical and Product Development teams.
- Translate complex manufacturing, biosensor, statistical and clinical performance outputs into clear decisions for technical, quality, regulatory and executive stakeholders.
- Compile algorithm requirements, data requirements, validation plans and analytical performance reports in alignment with regulated medical device standards.
- Generate evidence packages demonstrating algorithm validity, analytical performance and readiness for prospective validation.

Team Support & Flexibility:

- Be open to supporting team and company objectives in areas beyond your direct expertise.

Job type: 1 year contract

Qualifications:

- Bachelor’s, Master’s Degree or PhD in Chemical Engineering, Process Control, Process Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemometrics, Statistics, Biostatistics, Applied Mathematics, Analytical Chemistry, Measurement Science, Data Science with solid applied statistical modelling background, or a related discipline. Advanced coursework, research or industry experience in calibration transfer, process control, manufacturing process variation, real-time process measurement, analytical validation, chemometrics, biosensor calibration, diagnostic performance evaluation,



manufacturing statistics or medical device algorithm development preferred.

Experience:

- 5+ years of experience in one or more relevant technical fields, such as process control, process engineering, calibration modelling, manufacturing process analytics, biosensor/diagnostic algorithm development, analytical validation, chemometrics, process analytical technology, medical device statistics or related applied modelling fields.
- Demonstrated ability to use available process, sensor, manufacturing, QC or experimental data to explain system behaviour, predict performance, or develop practical real-time/near-real-time measures.
- Experience working with manufacturing process variation, DOE, CPP/CQA data, QC measurements, sensor genealogy, batch/lot effects, instrument variation, or equivalent sources of product/process variability.
- Demonstrated ability to build models or algorithms that generalise across changing conditions, such as sensors, batches, lots, instruments, sites, operators, process versions or manufacturing environments.
- Strong applied modelling capability, which may include regression, nonlinear modelling, energetic modelling, process control methods, chemometrics, variance decomposition, uncertainty estimation, grouped/prospective validation or related approaches.
- Ability to distinguish variation that can be modelled or calibrated from variation that should be controlled through manufacturing, chemistry, metrology, QC or release criteria.
- Strong understanding of analytical performance evaluation, including bias, limits of agreement, confidence intervals, prediction intervals, error budgets and clinically or operationally relevant performance metrics.
- Proficiency in Python, R, MATLAB or equivalent technical computing/statistical programming tools; SQL/Snowflake experience will be considered an advantage.
- Experience in regulated medical device, IVD, diagnostics, Continuous Glucose Monitoring (CGM), point-of-care testing, blood gas/lactate/glucose analysers, spectroscopy calibration, wearable biosensors or other complex sensor/process environments will be highly regarded.
- Strong organisational skills, attention to detail, critical-thinking mindset, curiosity, comfort with ambiguity, goal focus, collaborative working style and excellent written/verbal communication skills.

Additional information relevant to this position includes

- Work Location: Perth, Western Australia preferred, with hybrid arrangements available. Australia-wide or international candidates may be considered for exceptional calibration transfer, biosensor, IVD, CGM or analytical validation experience.
- Due to the nature of the position and industry, there may be a requirement to work outside normal business hours, particularly when working with international collaborators, consultants or regulatory partners.

📌 Product Algorithm Engineer-Continuous Biosensors (Malaga)
🏢 VitalTrace
📍 Malaga